What is Testosterone Therapy?
Testosterone is a hormone found naturally in both men and women. In men, testosterone is associated with the reproductive system as well as secondary sexual characteristics like larger muscles, denser bone mass and increased body hair. Even more noticeable are the side effects men suffer when they do not have enough testosterone production occurring in their bodies. This condition of low testosterone is known as hypogonadism.
Symptoms of hypogonadism typically start in men over 60, but can occur in younger men as well. The symptoms are also sometimes seen as the less serious “male menopause” or “andropause,” which are believed to be a part of the natural aging process in men.
These symptoms include:
- Low sex drive (libido)
- Erectile dysfunction
- Fatigue and poor energy level
- Difficulty concentrating
- Low sense of well-being
Low testosterone conditions should be established through a blood test. After tests confirm the diagnosis, the patient and his doctor may decide to seek treatment with drugs designed to increase the levels of testosterone in the body. The FDA has only approved these drugs for treatment of the more severe condition of hypogonadism rather than the general and normal condition of lowered testosterone that is associated with male aging.
Most of these treatments are referred to as “Testosterone Therapy” or “Testosterone Replacement Therapy.” This infusion of the hormone is through injections, implants, skin patches, gels or a mouth patch. (Pills are not generally used as they are thought to cause liver damage.) The most common brand names of these treatments are:
- Androderm (Actavis) – patch applied to the skin
- AndroGel (AbbVie Inc.) – topical gel applied to the skin
- Axiron (Lilly USA, LLC) – topical cream applied to underarm
- Bio-T-Gel (Teva Pharmaceuticals) – topical gel applied to skin
- Delatestryl (Endo Pharmaceuticals) – injection or solution
- Depo-Testosterone (Unigen Life Sciences) – injection solution
- Fortesta (Endo Pharmaceuticals) – topical gel applied to skin
- Striant (Auxilium Pharmaceuticals) – buccal tablet absorbed through the gums
- Testim (Auxilium Pharmaceuticals) – topical gel applied to skin
- Testopel (Auxilium Pharmaceuticals) – subcutaneous pellet
In 2011, 5.3 million prescriptions for testosterone treatments were written in the United States alone. In the last decade, prescriptions have tripled among men over 40. By 2012, sales in the United States had reached $2 billion annually. Bloomberg reports an expected $5 billion per year in sales of testosterone replacement drugs by 2017.
Recent Studies and FDA Investigation
On January 31, 2014, the FDA announced that it had begun investigating “the risk of stroke, heart attack and death in men using FDA-approved testosterone products.” It further stated that:
“We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.”
One of these studies was published November 6, 2013 in The Journal of the American Medical Association. The study followed 8,000 men treated as part of the Veterans Health Administration. The study concluded that “the use of testosterone therapy was associated with increased risk of adverse outcomes.” In this study, the risk of heart attack, stroke and death increased by 29%.
The study found a higher risk for patients who currently or previously suffered the following conditions:
• plaque build-up
• artery blockage
• high cholesterol
The other study that raised the FDA’s concern was conducted by UCLA and was published on January 19, 2014. The study followed over 50,000 men who been prescribed testosterone replacement therapy drugs and found that after 90 days of treatment, there was a 36% increase in the risk of myocardial infarctions, i.e., heart attacks. Other studies have shown a 61% increased risk of serious cardiovascular side effects.
Lawsuits Seek Damages for Injuries and Death
Lawsuits have been filed in several states claiming a variety of severe side effects and/or death as a result of using a testosterone therapy drug.
One suit filed on March 18, 2014 in the State of Pennsylvania alleges that the Plaintiff suffered “serious cardiovascular problems due to his use of Testim.” The suit also alleges that the Defendants (GlaxoSmithKline and Auxilium Pharmaceuticals, Inc.) engaged in an “aggressive and pervasive direct-to-consumer advertising campaign which suggested that low testosterone levels and ‘Low T’ were pathologic entities requiring treatment.” The suit further alleges that the drug is “unreasonably dangerous due to inadequate testing, warnings and instructions for use, which created significant health risks and threat of serious bodily harm to consumers at large.”
After the FDA announced its investigation, lawsuits increased in many states. In Illinois, five separate cases were filed against Abbott Laboratories and AbbVie, Inc., the makers of AndroGel. Multiple lawsuits have also been filed in the District Courts of California, Pennsylvania, and Ohio.
The lawsuits allege misleading marketing, including television commercials, and a lack of labeling that warns about potentially life-threatening heart problems and strokes. One attorney alleged that Testim was “drug in search of a reason to give it.”
The consumer advocacy group Public Citizen petitioned the FDA in February 2014. The group is seeking an FDA mandate that requires testosterone drugs to add a “black box” warning label. The group also wants the FDA to mandate warning letters be sent to doctors on the risks of testosterone therapy drugs. Public Citizen alleges that as many as 25% of men who took the drugs did not have their “low-T” condition confirmed with blood tests.
If you are considering taking a form of a testosterone replacement drug, ask your doctor for more information about the risks and benefits.
If you believe you or someone you know was injured by a testosterone replacement drug, consult with an attorney for information on filing a separate lawsuit or to make a claim as part of an existing class action lawsuit.
The FDA is also currently monitoring the voluntary reporting of adverse side effects. After consulting your doctor and possibly an attorney, you may also wish to submit a report to the FDA using this link: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm